At Eurotext Translations, we have helped many of the world’s largest medical devices manufacturers to significantly improve time-to-market delivery through the deployment of Eurotext’s linguistic services, superior project management and software solutions to manage the delivery of information across all target market languages.
We understand the particular requirements of this highly regulated industry, and work closely with our clients to ensure all their translated materials meet the communication needs of customers, physicians and patients.
As an ISO 9001:2008 certified organisation, we understand the need for process optimisation and the efficiencies and cost savings that this delivers. Entrusting your translation and localisation needs to Eurotext Translations, brings with it not only peace of mind but also savings to the bottom line. Our solutions ensure that your investment in translation goes a long way over a long period of time. Our content management and linguistic asset management programmes ensure that your translation investment delivers cost savings, quicker updates and faster time to market releases.
Medical device sector regulations specifically require manufacturers to provide their technical documents, product labeling, operating instructions and user manuals in the local language of the country where they will be used.
The main European directives for the medical device sector are as follows:
- Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (the AIMD Directive)
- Council Directive 93/42/EEC of 14 June 1993 (the Medical Device Directive)
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic (the In-Vitro Diagnostic Medical Device Directive)
In-country review by specialists in the local market is an indispensible element of the medical device translation process. This step can be as time-consuming as it is crucial. Eurotext has the experience and expertise needed to streamline and strengthen this process – see our case report for details of how we helped one customer get on top of their in-country review requirements
Our Translator Profiles
Our many years of experience in this area has allowed Eurotext to build a highly responsive, effective and managed panel of experienced technical and medical translation experts delivering effective solutions to medical devices organisations across the globe. Strong linguistic and technical writing expertise coupled with professional qualifications such as M.D. and Ph.D. in all major areas of life sciences, biomedical engineering and medicine ensure optimum results.
The translators and editors on our extensive panel boast an average of 10 years’ solid experience in translation and localisation for the medical devices sector. They are selected and recruited for their successful track record of translating, revising and reviewing technical and medical texts in line with the requirements set out by the European Standard for the provision of translation services EN 15038:2006. They are all native speakers of the target language and are based in-country, giving them full exposure to changing styles and preferences in their native languages.
Building on this strong base of experience and expertise, our quality control systems and methodology are also designed to meet the exacting requirements of the medical devices industry.
Our Medical Devices Sector Experience
Eurotext Translations provides reliable and professional translation solutions for the full range of medical device-related content, including:
- Operating, maintenance, and installation manuals
- Instructions for use
- Regulatory compliance documents for European Union and Asian countries.
- Software application interfaces and documentation
- Package inserts and labels
- Patents for medical and surgical devices
- Manufacturing process descriptions